Following an inspection from June 16 to July 31, the FDA issued a Form 483 with seven inspectional observations, two of which are designated as repeat observations.
But the FDA did not provide any status or classification to these observations and will defer classification until it has reviewed Impax's response to the inspection. The Company is working diligently to addressthe agency’s observations and will respond to them within 15 days, Impax said.
The FDA criticized Impax in the 483 for failing to establish and document the accuracy, sensitivity and reproducibility of test methods. One of the repeat observations also called the company out for failing to provide enough detail in its written procedures for cleaning and maintenance.
"Addressing these latest observations and advancing our quality improvement initiatives are our top priorities," said Fred Wilkinson, president and CEO of Impax. "Our dedicated teams are focused on creating a world class quality organization."
"While the past week has been challenging, I remain enthusiastic about Impax's future and the opportunities ahead of us. We have a track record of development and commercialization success, and a strong pipeline of pending products. In addition, we have the financial resources and balance sheet to create new revenue sources through internal and external development, while pursuing strategic and accretive M&A opportunities," Wilkinson said.
Despite the multiple 483s, Impax on Wednesday reported total revenues increased 45.1% to $188.1m for Q2, compared to $129.6m in the prior year period.